Sustainable Food Contact Material in China
National Reference Laboratory for Food Contact Material (Guangdong) Guangzhou Customs Technology Center
Oscar [email protected]
• IQTC is based in Guangzhou and is one of leading institute in China,under the organization of China Customs, with a history of more than 40 years ,dedicating to provide the technical service for government and industry, particularly on food, food packaging and consumer products
• IQTC-FCM ,a national reference lab ,the chairman of China Food Industry FCM experts committee, specialized in regulatory, testing and risk assessment for food contact materials
About IQTC-FCM
Guangzhou
National Risk Monitoring
Regulatory
Testing Service for Compliance
InternationalFCM Safety Symposium
2
ResearchResearch
and Develop
CONTENTS
Part 1
Background
Part 2
Current Situation in China
Part 3
IQTC’s work and Findings
Part 4
Summary
3
Since the invention of food package, we’ve been using it for more than a thousand years….
4
Plastic is one of the greatest 100 inventions in human history.
• Aerospace technology
• Cars and ships
• Electrical and electronic
appliances
• Food packaging
• Modern agriculture
• Processing machinery
• Medical and pharmaceutical
sciences
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Prevent chemical/biological contamination
Avoid spoilage
long distance transportation
long-term storage
Natural protection
• Build a brand• Improve consumer experience• Address hunger
1/4-1/3 food get spoiled815m hungry people around the world
Packing protection
Plastic food packaging: most important role to make food into a food product
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Improper use/disposal of plastics: serious marine ecological safety problems
8 million tons of plastics end up in the ocean
Centuries to be fully biodegraded
Loss of $130 billion per year, weight of plastic wastes
in the ocean> total weight of fish till 2050
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Plastic waste is huge and difficult to recycle and biodegrade
8.3 billion(1st
half 2017)/6.3 billion(2015) tons of waste
plastics
9% recycled14%recycled
• C-C chemical bond is difficult to degrade• Blending compounds: difficult to separate and
difficult to classify• cross-linked structure; insoluble, infusible, difficult
to process
25-35%Plastic
package for food
Source: Sci. Adv. 2017;3 19 July20178
Improper use/disposal of plastics: serious biological and food safety problems
Marine trash: Endanger Marine biological safety, 50% beach wastes are single use disposable plasticsMicroplastics: food safety and health risks
Source:海洋塑料微塑料污染及应对,中国海洋报,2018-12-18
Marine pollution of plastic micro-debris in China is at the medium level• Nearshore fish: 1.1-7.2 items per fish,
• Seashells: 0.9-4.6 items per gram of soft tissues
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Global Action - Promoting Plastic Pollution Governance for Sustainable Development
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Priority : Promote the sustainable development of Food Contact Materials
02
04
01
03
UNEP #CleanSeas CampaignBy 2022
eliminate major sources of pollution, including microplastics in cosmetics and single-use disposable plastics
European StrategyBy 2025,>55% plastics are recyclableBy 2030, 100% of plastics packaging is reusable or recyclable
Restrict/ban single use disposable plastics27 countries ban single use disposable plastics29 countries impose special tax on single use disposable plastics63 countries introduce EPR (Extended Producer Responsibility) approach
Industry Action2025 commitmentPublic educationInnovation and practice(design/recycle/biodegradation) 11
• Using biodegradable material to replace oil-based plastic
The production volume of PLA、PHA are increasing
The main approach taken on FCM
Source: European Bioplastics, nova-Institute (2016).
• Encouraging the use of recycled materials(R-PET)
EC proposed to approve >100 application of R-PET in FCM in 2019
21% R-PET containers were used for FCM and beverage bottle*
*: The National Association for PET Container Resources 12
CONTENTS
Part 1
Background
Part 2
Current Situation in China
Part 3
IQTC’s work and Findings
Part 4
Summary
13
• 废 waste sorting/
• segregation
• Ban single-use food packaging
• Recycled and reuse of
• Plastic
• China Customs banned the import of solid waste
Control the import
Reuse
Management of waste
Reduce/
Replace
China is active on Sustainability
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China's initiative: encourage recycling
June 5, 2019: Law of the People's Republic of China on the Prevention and Control of Environmental Pollution by Solid Wastes (Revised Draft)
2018: Revision of the Catalogue of Imported Waste Management
2017: “Initiative to Guide The Shift Toward Circular Development "plans to increase the recycling of major wastes from 47.6% in 2015 to 54.6% by 2020.
2015: “Specifications for the Industry of Comprehensive Utilization of Waste Plastics” and “Interim Regulations on the Announcement and Management System of Specifications for the Industry of Comprehensive Utilization of Waste” (Ministry of Industry and Information Technology)
2012: “Regulations on the Prevention and Control of Waste Plastics Processing and Utilization” (Ministry of Environmental Protection) ; Technical Specification for Pollution Control of Waste Plastics Recycling and Recycling (HJ/T 364-2007)
2010: Recycled plastic must not be used in plastic food containers, packaging materials, utensils, etc. Abolished in Dec
2008: Notice on Restricting Production and Sales of Plastic Shopping Bags (ODD, 2008)
The sheet of R-PET produced by Yingchuang was authorized to be used for manufacturing of food grade PET
2007: Regulations on the Management of Recycling Resources
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In 2015, Jilin became the first province in China that banned single use non-degradable plastic products.
Single use non-biodegradable plastic bags and plastic tableware will be banned to manufacture, sell or usein Hainan province by 2020.
The production, sale and use of the plastic products listed in the Catalog of Non-degradable Single Use Plastic Products Banned In Hainan Province, in addition to bags and tableware, will be prohibited by 2025 in the province,
China Initiative: Restricting single use disposable plastic products
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China: largest country to produce plastics: 30%
China's food and beverage industry posted a record high of around 4.3 trillion yuan in revenue in 2018,accounted for 11.2% of the total volume of retail sales, and 4.7% of the total volume of National GDP
The waste volume obtain from take way single-use food packaging in China is staggering
Impact to China Food Industry
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Question:Can biodegradable or recycled materials be directly used to make FCMs in China?
• Consumer misuse• Non-food application• Degradation• Chemicals from other
materials • Chemicals used in the
recycling process
• Mineral oil
• Phthalates
• Photo-initiator
• Anti-oxidant
• Pesticides
• Oligomer
……
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The Management system on FCMs was reshaped
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Boarder control
General Administration of Customs of China
Official control on FCM
NHC
China Customs
SAMR
Domestic official control
Regulation (Mandatory standard )
National Heath commission
State Administrationfor Market Regulation
Framework legislation
Specific Standards Paper and Board
GB 4806.8-2016
GlassGB 4806.5-2016
GB 4806.1-2016General safety requirement
GB 9685-2016
MetallicGB 4806.9-2016
CeramicGB 4806.4-2016
PlasticGB 4806.7-2016
Plastic ResinGB 4806.6-2016
RubberGB 4806.11-2016
CoatingGB 4806.10-2016
Wood/bamboo/Cork
GB 31603-2015
Screening
General guidance
GB 31604.1-2015
PretreatmentGB 5009.156-
2016
GMP
Laminated materials
TeatGB 4806.2-2015
Adhesive
OMGB 31604.8-2015
KMNO4GB 31604.2-2015
Heavy metal(Pb)
GB 31604.9-2015
De-colorGB 31604.7-2015
EnamelGB 4806.3-2016
Inks………….
SMGB 31604.10~49
RESTRICTION
TESTING
Positive list For additives
QMMigration
New GB Regulation System on FCM: Enforced Since 2017
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The latest development for FCM legislations
Reviewed by Committee
GB 4806.X Multilayer material and
articles
GB 4806.X Wood, Bamboo and
Cork
GB 4806.X Starch based material
GB 31604.X PAAs migration
GB 31604.X NP migration
GB 31604.X acrylic acid and
methacrylic acid migration
On processing/Consultation
GB 4806.X Printing Ink
GB 4806.X Regenerated
cellulose film
GB 4806.X Adhesive
GB 31604.X Ethylene-2-
norbornene migration
GB 31604.X Solvent residual
Kick off Revision
GB 4806.6 Plastic resin
GB 4806.7-2016 Plastic
GB 4806.8-2016 Paper and board
GB 4806.9-2016 Metallic
GB 4806.10-2016 Coating
GB 4806.11-2016 Rubber
GB31604.1 Guide to migration
test
GB31604.30 Phthalates
GB31604.47 OBA in paper
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Covering the whole supply chain: from chemicals to the table
GMP
• Production
• Traceability• Control of
Set-off
Positive list
• PL for resin
• PL for additives
• Notification
system
Migration Limit & DoC
• Specific migration, overall migration
• Declaration of compliance(DoC)
General safety requirement
GB 9685
GB
31603
GMP
Notification
Specific
GB
Need to full fill the requirements of GB
standards
Core requirement: Three of “shall not”• Shall not endanger the human health under intended/foreseeable use • Shall not cause the change of composition and organoleptic characters• Shall not cause technical effects to food
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Application form
Chemical identification, physical and chemical properties
Technical justification, function and condition
Manufacturing process
Quality specification, test methods and test reports
Toxicological data
Migration Study
exposure assessment
Regulatory status in other countries
Relevant documents for petition of new substance if it is imported
Other documents useful for the expert pannel review (ISO Certificate etc.)
Information for public notification
New Petition (Single approve)
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Sustainability Safety
Food Industry
Safety/Risk evaluation leads to solutions
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CONTENTS
Part 1
Background
Part 2
Current Situation in China
Part 3
IQTC’s work and Findings
Part 4
Summary
25
An investigation on safety of biodegradable and recycled materials intend for contact with food
•PLA
•R-PET
•R-PE
•R-Paper and board
• Compliance of
specified limitation
• Assessment of NIAS
as requested by
framework regulation
FCMs Compliance check Techniques
• HS-GC-MS
• IR
• GC×GC-TOFMS
• UPLC-TOFMS
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0
2
4
6
8
10
12
14
1# 2# 3# 4# 5# 6# 7# 8# 9# 10# 11# 12# 13# 14# 15# 16# 17# 18# 19#
迁移量
(mg/d2)
样品
OM (95% ethanol, 60 ℃, 2h)
Biodegradable materials - PLA PLA: Compliance of specified limitation
Sample Restriction/Limitation
19 samples Sensory evaluation
Overall migration10% ethanol 60 ℃, 2h95% ethanol, 60 ℃, 2h
potassium permanganate consumption
Decolor test
heavy metal
One sample failed to comply with OML (95% ethanol, 60 ℃, 2h)
PLA , as kind of plastic , shall comply with the plastic Regulation: GB4806.7
27
PLA : NIAS assessment
Volatile compounds are not detected by HS-GC-MS
Certain type of semi-volatile compounds were found in 95% ethanol (60 ℃, 2h) by GC-MS
Mainly screened
substances
Possible
applicationCAS No Authorized?
Crammer classification
lactide monomer 95-96-5/4511-42-6 IAS Y Class I
lactic acid monomer 50-21-5 IAS YClass I
Methyl palmitate
lubricant
112-39-0 NIAS NClass I
Palmitate acid 57-10-3 NIAS NClass I
Ethyl palmitate 628-97-7 NIAS NClass I
Methyl stearate 112-61-8 NIAS NClass I
Stearic acid 57-11-4 IAS Y Class I
Eethyl stearate 111-61-5 NIAS N Class I
DEHP plasticizer 117-81-7 IAS Y Class I
2 0 4 0 6 0 8 0 1 0 0 1 2 0 1 4 0 1 6 0 1 8 0 2 0 0 2 2 0 2 4 0 2 6 00
2 0 0
4 0 0
6 0 0
8 0 0
1 0 0 0
1 2 0 0
1 4 0 0
1 6 0 0
1 8 0 0
2 0 0 0
2 2 0 0
2 4 0 0
2 6 0 0
m / z - - >
? ?
? ? 1 0 4 1 ( 1 4 . 3 1 8 ? ) : 2 4 3 6 - 4 # - 9 5 % - 1 . D \ d a t a . m s7 4 . 0
4 1 . 1
2 2 7 . 11 4 3 . 0
2 7 0 . 0
1 9 9 . 09 6 . 9
1 7 1 . 0
palmitic acid
methyl palmitate
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• Glyceryl triacetate, di (2-ethylhexyl) adipate (DEHA) are authorized plasticizers
• The OD-PABA is not in the list of GB 9685, but belongs to Cramer class I.
Nonvolatile compounds --- UPLC-Q-TOF
The commercial PLA sold in the market pose less safety concern.
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Sample Limitation
9 samples
Lead (4% acetic acid, reflux 0.5h) water
extract (reflux, 0.5h)
4% acetic acid extract (reflux, 0.5h)
65% ethanol extract (reflux, 2h)
n-hexane extract (reflux, 1H)
water extract (reflux, 0.5h)
PET-1
Recycled materialsR-PET: Compliance of specified limitation
> 90% compliance
• The non-compliance cases : 65% ethanol extract (reflux, 2h), n-hexane extract (reflux, 1H), water extract (reflux, 0.5h).• Identification of non-compliance sample : the extract refer to PET or POM polymer(polyformaldehyde)
R-PET Particle shall comply with Plastic resin Regulation B4806.6
Infrared spectrum
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R-PET: Volatiles and semi volatiles compounds
91 semi volatile compounds were foundSemi volatile compounds : GC×GC-TOFColumn set: weak polar–nonpolar (DB-17-DB-5)
classification of compounds
numberProportion of peak
area
Ketone 12 38.69%
ester 40 17.84%
phthalate 6 10.94%
phenol 10 7.20%
alkane 2 1.35%
The following compounds were detected with concentration above 7 mg/kg
· DEHP, which is only allowed to be used in PVC. SML = 1.5mg / kg
· 3,6,13,16-tetraoxtricyclo [16.2.2 (8,11)] tetracosa-8,10,18,20,21,23-
hexaene-2,7,12,17-tetrane is classified as NIAS and Cramer III
. 2-pentadecylfuran is NIAS and Cramer III.31
21 compounds were detected:• Oligomers (Tetraethylene glycol, terephthalic acid bis (2-hydroxyethyl) ester), • Fungicides (4-chlorobenzoic acid), • Antioxidants (antioxidant 245, etc.), • Surfactants (sulfonated Di-isooctyl succinate), • Plasticizers (o-benzene, citric acid ester), • Photo-initiators (photo-initiators 907, etc.), • flame retardants (tris (butyl-oxyethyl) phosphate). • UV absorber (UV-9)...
R-PET :Nonvolatile compounds
• Number of semi volatile and non-volatile compounds were detected in R-PET particles• Some of compounds are NIAS, not in the positive list , caution and further investigated is needed if they are
used for FCMs.
Photo-initiator, not in GB 9685 positive list ,Cramer Class III
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R-PE: Compliance of specified limitation
• Inorganic filler may be the main cause of non-compliance
Sample Limitation compliance
9Particle samples
Loss on drying (90 ℃ ~ 95 ℃, 2h) burning residue(90℃~95℃,2h)
Y
all qualified n-hexane extract (reflux, 2h) Y
burning residue 7 samples no comply
albite
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Sample Limitation compliance
7 samples Sensory (sample) Y
Heavy metals (as Pb)(4% acetic acid, 60℃, 2h)
Y
As Y
Formaldehyde extractive(water, 80℃, 2h)
Y
Migration of BPA(4% acetic acid, 70℃, 2h)
Y
Overall migration(10% ethanol, 70℃, 2h)
Y
Overall migration(4% acetic acid, 70℃, 2h)
Y
Extractable chloropropanol(water,80℃,2h) N
Pb N
Potassium permanganate consumption(distilled water, 60℃, 2h)
N
Fluorescent substances(at wavelength of 254nm and 365nm)
N
Sensory (simulant) N
• All tested samples does not comply
• Check the compliance against GB 4806.8
R-Paper: Compliance of specified limitation
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253 compounds detected
classification of compounds
numberProportion of
peak area
alkane 52 56.67%
nitrogen compounds 7 13.67%
ketone 8 8.39%
acid 13 6.16%
Polyphenyl ring compounds
5 2.37%
ether 5 1.97%
alcohol 10 1.61%
Halogen compounds 3 1.57%
cycloalkane 19 1.23%
benzene compounds 18 0.76%
ester 12 0.46%
phenolic compounds 2 0.43%
sulfur compounds 3 0.22%
R-Paper: volatiles and semi volatiles compounds
Semi volatile compounds analysis :GC×GC-TOF
MOSH
• Mineral oil is commonly detected in recycled paper; • The characteristic compounds in recycled paper are hexadecylic acid,
octadecanoic acid (crameri), 16-31 ketone, 18-35 ketone (crameri class II); • The content of characteristic compounds were usually above 10 ppm by semi
quantitative analysis.
35
Prof. Marco Zhong
Prof. Li Dan, Dr. Liu Hong,
Dr. Pan Jingjing, Dr. Ren Zhaofang
Prof. Qinbao Lin
Zhifeng Chen, Lixian Zhu
Project team
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CONTENTS
Part 1
Background
Part 2
Current Situation in China
Part 3
IQTC’s work and Findings
Part 4
Summary
37
• Sustainability is hot topic in the world, China is active
• Food safety is the bottom line , China has reshaped the management system on FCMs
• The studied of commercial PLA FCMs pose less safety concern ;There are certain type of high
concerned compounds found in the recycled materials, which may pose a safety concern with
their toxicity characterization.
• More investigation are needed for the migration of recycled materials and degradable materials
to provide more accurate data for the risk assessment
• For recycled materials and degradable materials(except PLA、PBAT、PBS) intended to be used
for food contact, the new petition process for every single case is necessary
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Safety is non-negotiable Sustainability of FCM is demanded
IQTC
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